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of the specialized scientific and managerial nature of our business, we rely heavily on our ability to attract and retain qualified scientific, technical and managerial
personnel. We do not currently carry "key person" insurance on the lives of members of executive management. The competition for qualified personnel in the pharmaceutical field is intense. Due to this
intense competition, we may be unable to continue to attract and retain qualified personnel necessary for the development of our business or to recruit suitable replacement personnel. In addition, we
rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy including, F. Nicholas
Franano, our scientific founder. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may
limit their availability to us.
We will need to significantly increase the size of our organization, and we may experience difficulties in managing growth.
We are currently a small company with 11 full-time employees and one part-time employee as of September 30, 2014. In order to
commercialize our potential products, we will need to increase our operations and expand our use of our third-party contractors. We plan to continue to build our compliance, financial and operating
infrastructure to ensure the maintenance of a well-managed company including hiring additional staff within our regulatory and clinical groups after Phase 3 is complete. We intend to recruit an
in-house commercial organization in the United States focused on promoting PRT-201, if it is approved. We currently do not have a sales and marketing capability and therefore intend to recruit a
specialty hospital sales force of approximately 75-100 representatives in anticipation of PRT-201's approval. We estimate it will take three to six months to recruit this specialty hospital sales
force. We will need to expand our employment base when we are in the full commercial stages of our current potential product's life cycle.
growth will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees. In addition,
to meet our obligations as a public company, we will need to increase our general and administrative capabilities. Our management, personnel and systems currently in place may not be adequate to
support this future growth. Our future financial performance and our ability to commercialize our potential products and
to compete effectively will depend, in part, on our ability to manage any future growth effectively. To that end, we must be able to:
- manage our clinical trials and the regulatory process effectively;
- manage the manufacturing of product candidates and potential
products for clinical and commercial use;
- integrate current and additional management, administrative, financial and sales and marketing personnel;
- develop a marketing and sales infrastructure;
- hire new personnel necessary to effectively commercialize PRT-201 and any
additional product candidates;
- develop our administrative, accounting and management information systems and controls; and
- hire and train additional qualified personnel.
candidates that we may acquire or develop in the future may be intended for patient populations that are large. In order to continue development and marketing of these product
candidates, if approved, we would need to significantly expand our operations. Our staff, financial resources, systems, procedures or controls may be inadequate to support our operations and our
management may be unable to manage successfully future market opportunities or our relationships with customers and other third parties.